Dataset Information

Counselling-based psychosocial intervention to improve the mental health of abused pregnant women: a protocol for randomised controlled feasibility trial in a tertiary hospital in eastern Nepal.

ABSTRACT:

Introduction

The strong correlation between domestic and family violence (DFV) and mental health has been well documented in studies. Pregnancy is a period when both DFV and mental distress tend to occur and/or accentuate. Although limited, available evidence from developed countries has shown continual support and education as psychological first aid that can reduce DFV and improve mental health. However, there is significantly less number of studies from resource-constrained countries; thus, there continues to be a substantial gap in knowledge and awareness regarding effective interventions for DFV.

Methods and analysis

A two-arm randomised trial with a nested qualitative study has been planned to assess feasibility and treatment effect estimates of a counselling-based psychosocial intervention among pregnant women with a history of abuse. A total of 140 pregnant women who meet the inclusion criteria will be recruited into the study. Block randomisation will be used to allocate women equally into two groups. The intervention group will receive a counselling session, an information booklet and continuous support by a researcher, while women in the control group will receive contact information of local support services. Feasibility measures, such as rates of recruitment, consent and retention, will be calculated. Qualitative interviews with participants and healthcare providers will explore the acceptability and usability of the intervention. Outcome measures, such as psychological distress, quality of life, social support and self-efficacy, will be measured at baseline, 4 weeks postintervention and 6 weeks postpartum.

Ethics and dissemination

This study has obtained ethical approval from the Griffith University Human Research Ethics Committee, the Nepal Health Research Council and the Institutional Review Board of a tertiary hospital in Dharan, Nepal. The findings will be disseminated via peer-reviewed publications and conference presentations and will be used to inform a future multicentre trial.

Trial registration number

12618000307202; Pre-results.

SUBMITTER: Sapkota D

PROVIDER: S-EPMC6500424 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Counselling-based psychosocial intervention to improve the mental health of abused pregnant women: a protocol for randomised controlled feasibility trial in a tertiary hospital in eastern Nepal.

Sapkota Diksha D Baird Kathleen K Saito Amornrat A Rijal Pappu P Pokharel Rita R Anderson Debra D

BMJ open 20190423 4

<h4>Introduction</h4>The strong correlation between domestic and family violence (DFV) and mental health has been well documented in studies. Pregnancy is a period when both DFV and mental distress tend to occur and/or accentuate. Although limited, available evidence from developed countries has shown continual support and education as psychological first aid that can reduce DFV and improve mental health. However, there is significantly less number of studies from resource-constrained countries; ...[more]

PMID: 31015275

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Project description:AIMS:Psychological interventions that are brief, acceptable, effective and can be delivered by non-specialists are especially necessary in low- and middle-income countries, where mental health systems are unable to address the high level of psychosocial needs. Problem Management Plus (PM+) is a five-session intervention designed for those impaired by psychological distress while living in communities affected by adversity. Individual PM+ has demonstrated effectiveness in reducing distress in Kenya and Pakistan, and a group version of PM+ (Group PM+) was effective for conflict-affected women in Pakistan. This paper describes a feasibility and acceptability trial of locally adapted Group PM+ for women and men in an earthquake-affected region of rural Nepal. METHODS:In this feasibility cluster randomised controlled trial, participants in the experimental arm were offered five sessions of Group PM+ and participants in the control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG). A mixed-methods design was used to assess the feasibility and acceptability of Group PM+. Feasibility was assessed with criteria including fidelity and retention of participants. Acceptability was assessed through in-depth interviews with participants, family members, programme staff and other stakeholders. The primary clinical outcome was depression symptoms assessed using the Patient Health Questionnaire (PHQ-9) administered at baseline and 8-8.5 weeks post-baseline (i.e. after completion of Group PM+ or EUC). RESULTS:We recruited 121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1). Group PM+ was delivered over five 2.5-3 hour sessions by trained and supervised gender-matched local non-specialists, with an average attendance of four out of five sessions. The quantitative and qualitative results demonstrated feasibility and acceptability for non-specialists to deliver Group PM+. Though the study was not powered to assess for effectiveness, for all five key outcome measures, including the primary clinical outcome, the estimated mean improvement was larger in the Group PM+ arm than the EUC arm. CONCLUSION:The intervention and trial procedures were acceptable to participants, family members, and programme staff. The communities and participants found the intervention to be beneficial. Because feasibility and acceptability were established in this trial, a fully powered randomised controlled trial will be conducted for larger scale implementation to determine the effectiveness of the intervention in Nepal.

Project description:BackgroundThe prevalence of common mental disorders increases in humanitarian emergencies while access to services to address them decreases. Problem Management Plus (PM+) is a brief five-session trans-diagnostic psychological WHO intervention employing empirically supported strategies that can be delivered by non-specialist lay-providers under specialist supervision to adults impaired by distress. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the efficacy of individually delivered PM+. To make PM+ more scalable and acceptable in different contexts, it is important to develop a group version as well, with 6-8 participants in session. A study is needed to demonstrate the feasibility and acceptability of both the intervention in a new cultural context and the procedures to evaluate Group PM+ in a cluster randomized controlled trial.MethodsThis protocol describes a feasibility trial to Group PM+ in Sindhuli, Nepal. This study will evaluate procedures for a cluster randomized controlled trial (c-RCT) with Village Development Committees (VDCs), which are the second smallest unit of government administration, as the unit of randomization. Adults with high levels of psychological distress and functional impairment will receive either Group PM+ (n = 60) or enhanced usual care (EUC; n = 60). Psychological distress, functional impairment, depression symptoms, posttraumatic stress disorder (PTSD) symptoms, and perceived problems will be measured during screening, pre-treatment baseline, and 7-10 days after the intervention. Qualitative data will be collected from beneficiaries, their families, local stakeholders, and staff to support quantitative data and to identify themes reporting that those involved and/or effected by Group PM+ perceived it as being acceptable, feasible, and useful. The primary objective of this trial is to evaluate the acceptability and feasibility of the intervention; to identify issues around implementation of local adaptation methods, training, supervision, and outcomes measures; and to assure that procedures are adequate for a subsequent effectiveness c-RCT.DiscussionOutcomes from this trial will contribute to optimizing feasibility and acceptability through cultural adaptation and contextualization of the intervention as well as refining the design for a c-RCT, which will evaluate the effectiveness of Group PM+ in Nepal.Trial registrationClinicalTrials.gov identifier: NCT03359486.

Project description:BACKGROUND:Pregnancy and parenthood are known to be high-risk times for mental health. However, less is known about the mental health of pregnant adolescents or adolescent parents. Despite the substantial literature on the risks associated with adolescent pregnancy, there is limited evidence on best practices for preventing poor mental health in this vulnerable group. This systematic review therefore aimed to identify whether psychosocial interventions can effectively promote positive mental health and prevent mental health conditions in pregnant and parenting adolescents. METHODS:We used the standardized systematic review methodology based on the process outlined in the World Health Organization's Handbook for Guidelines Development. This review focused on randomized controlled trials of preventive psychosocial interventions to promote the mental health of pregnant and parenting adolescents, as compared to treatment as usual. We searched PubMed/Medline, PsycINFO, ERIC, EMBASE and ASSIA databases, as well as reference lists of relevant articles, grey literature, and consultation with experts in the field. GRADE was used to assess the quality of evidence. RESULTS:We included 17 eligible studies (n =?3245 participants). Interventions had small to moderate, beneficial effects on positive mental health (SMD?=?0.35, very low quality evidence), and moderate beneficial effects on school attendance (SMD?=?0.64, high quality evidence). There was limited evidence for the effectiveness of psychosocial interventions on mental health disorders including depression and anxiety, substance use, risky sexual and reproductive health behaviors, adherence to antenatal and postnatal care, and parenting skills. There were no available data for outcomes on self-harm and suicide; aggressive, disruptive, and oppositional behaviors; or exposure to intimate partner violence. Only two studies included adolescent fathers. No studies were based in low- or middle-income countries. CONCLUSION:Despite the encouraging findings in terms of effects on positive mental health and school attendance outcomes, there is a critical evidence gap related to the effectiveness of psychosocial interventions for improving mental health, preventing disorders, self-harm, and other risk behaviors among pregnant and parenting adolescents. There is an urgent need to adapt and design new psychosocial interventions that can be pilot-tested and scaled with pregnant adolescents and adolescent parents and their extended networks, particularly in low-income settings.

Project description:BackgroundFunctional recovery in psychosis remains a challenge despite current evidence-based treatment approaches. To address this problem, innovative interventions using virtual reality (VR) have recently been developed. VR technologies have enabled the development of realistic environments in which individuals with psychosis can receive psychosocial treatment interventions in more ecological settings than traditional clinics. These interventions may therefore increase the transfer of learned psychosocial skills to real-world environments, thereby promoting long-term functional recovery. However, the overall feasibility and efficacy of such interventions within the psychosis population remain unclear.ObjectiveThis systematic review aims to investigate whether VR-based psychosocial interventions are feasible and enjoyable for individuals with psychosis, synthesize current evidence on the efficacy of VR-based psychosocial interventions for psychosis, and identify the limitations in the current literature to guide future research.MethodsThis research followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Literature searches were conducted in PubMed and PsycINFO in May 2021. We searched for peer-reviewed English articles that used a psychosocial intervention with a VR component. Participants in the included studies were diagnosed with schizophrenia, schizoaffective disorder, or another psychotic disorder. The included studies were divided into four categories as follows: cognitive remediation interventions, social skills interventions, vocational skills interventions, and auditory verbal hallucinations and paranoia interventions. The risk of bias assessment was performed for each study.ResultsA total of 18 studies were included in this systematic review. Of these 18 studies, 4 (22%) studies used a cognitive remediation intervention, 4 (22%) studies used a social skills intervention, 3 (17%) studies used a vocational skills intervention, and 7 (39%) studies implemented an intervention aimed at improving auditory verbal hallucinations or paranoia. A total of 745 individuals with psychosis were included in the study. All the studies that evaluated feasibility showed that VR-based psychosocial interventions were feasible and enjoyable for individuals with psychosis. The preliminary evidence on efficacy included in this review suggests that VR-based psychosocial interventions can improve cognitive, social, and vocational skills in individuals with psychosis. VR-based interventions may also improve the symptoms of auditory verbal hallucinations and paranoia. The skills that participants learned through these interventions were durable, transferred into real-world environments, and led to improved functional outcomes, such as autonomy, managing housework, and work performance.ConclusionsVR-based interventions may represent a novel and efficacious approach for improving psychosocial functioning in psychosis. Therefore, VR-based psychosocial interventions represent a promising adjunctive therapy for the treatment of psychosis, which may be used to improve psychosocial skills, community functioning, and quality of life.

Project description:AimsTwo large earthquakes in 2015 caused widespread destruction in Nepal. This study aimed to examine frequency of common mental health and psychosocial problems and their correlates following the earthquakes.MethodsA stratified multi-stage cluster sampling design was employed to randomly select 513 participants (aged 16 and above) from three earthquake-affected districts in Nepal: Kathmandu, Gorkha and Sindhupalchowk, 4 months after the second earthquake. Outcomes were selected based on qualitative preparatory research and included symptoms of depression and anxiety (Hopkins Symptom Checklist-25); post-traumatic stress disorder (PTSD Checklist-Civilian); hazardous alcohol use (AUDIT-C); symptoms indicating severe psychological distress (WHO-UNHCR Assessment Schedule of Serious Symptoms in Humanitarian Settings (WASSS)); suicidal ideation (Composite International Diagnostic Interview); perceived needs (Humanitarian Emergency Settings Perceived Needs Scale (HESPER)); and functional impairment (locally developed scale).ResultsA substantial percentage of participants scored above validated cut-off scores for depression (34.3%, 95% CI 28.4-40.4) and anxiety (33.8%, 95% CI 27.6-40.6). Hazardous alcohol use was reported by 20.4% (95% CI 17.1-24.3) and 10.9% (95% CI 8.8-13.5) reported suicidal ideation. Forty-two percent reported that 'distress' was a serious problem in their community. Anger that was out of control (symptom from the WASSS) was reported by 33.7% (95% CI 29.5-38.2). Fewer people had elevated rates of PTSD symptoms above a validated cut-off score (5.2%, 95% CI 3.9-6.8), and levels of functional impairment were also relatively low. Correlates of elevated symptom scores were female gender, lower caste and greater number of perceived needs. Residing in Gorkha and Sindhupalchowk districts and lower caste were also associated with greater perceived needs. Higher levels of impaired functioning were associated with greater odds of depression and anxiety symptoms; impaired functioning was less strongly associated with PTSD symptoms.ConclusionsFour months after the earthquakes in Nepal, one out of three adults experienced symptoms of depression and distressing levels of anger, one out of five engaged in hazardous drinking, and one out of ten had suicidal thoughts. However, posttraumatic stress symptoms and functional impairment were comparatively less frequent. Taken together, the findings suggest that there were significant levels of psychological distress but likely low levels of disorder. The findings highlight the importance of indicated prevention strategies to reduce the risk of distress progressing to disorder within post-disaster mental health systems of care.

Project description:ObjectivesTo examine the feasibility and acceptability of integrating a 'designated' approach to community health worker (CHW)-delivered mental health counselling (where existing CHWs deliver counselling in addition to usual duties) and a 'dedicated' approach (where additional CHWs have the sole responsibility of delivering mental health counselling) into chronic disease care.DesignA feasibility test of a designated and dedicated approach to CHW-delivered counselling and qualitative interviews of CHWs delivering the counselling.SettingFour primary healthcare clinics in the Western Cape, South Africa allocated to either a designated or dedicated approach and stratified by urban/rural status.ParticipantsForty chronic disease patients (20 with HIV, 20 with diabetes) reporting hazardous alcohol use or depression. Interviews with seven CHWs.InterventionThree sessions of structured mental health counselling.Main outcome measuresWe assessed feasibility by examining the proportion of patients who were willing to be screened, met inclusion criteria, provided consent, completed counselling and were retained in the study. Acceptability of these delivery approaches was assessed through qualitative interviews of CHWs.ResultsRegardless of approach, a fair proportion (67%) of eligible patients were willing to receive mental health counselling. Patients who screened positive for depression were more likely to be interested in counselling than those with hazardous alcohol only. Retention in counselling (85%) and the study (90%) was good and did not differ by approach. Both dedicated and designated CHWs viewed the counselling package as highly acceptable but requested additional training and support to facilitate implementation.ConclusionsDedicated and designated approaches to CHW-delivered mental health counselling were matched in terms of their feasibility and acceptability. A comparative efficacy trial of these approaches is justified, with some adjustments to the training and implementation protocols to provide further support to CHWs.

Dataset Information

Counselling-based psychosocial intervention to improve the mental health of abused pregnant women: a protocol for randomised controlled feasibility trial in a tertiary hospital in eastern Nepal.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Counselling-based psychosocial intervention to improve the mental health of abused pregnant women: a protocol for randomised controlled feasibility trial in a tertiary hospital in eastern Nepal.

Similar Datasets

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